The soft tissue of a sternal wound takes about 4-5 weeks to heal and the sternum bone between 6-8 weeks for a proper healing. In this postoperative period there are only the internal stainless steel wires, bands, plates or other devices to keep the thorax integrity intact. If the sternum bone closure is not stable, the soft tissue of the sternum wound may not be strong enough alone to support the sternum in case of excessive strain as during coughing, sneezing, exercises, or sudden movements involving the patient's upper extremities.
Effective methods to prevent postoperative complications in the healing period are crucial to decrease the costs of health care. The overall incidence of deep sternal wound infections (DSWI) after sternotomy procedures ranges from 0.3% to 5% during hospitalization with a morbidity between 14% and 47% and increases the length of hospital stay with additional 4 to 8 weeks. The incidence of DSWI increases to 7.3% at 90 days after discharge. Superficial sternal wound infections (SWI) are reported to be from 0.5% to 8% in the hospital, and increases to 9% after 90 days. Twenty five (25) % of SWI and more than 33% of DSWI cases are diagnosed between 30 and 90 days after surgery, while as many as 50% of SWI and 80% of DSWI are diagnosed at 90 days post-discharge. Postoperative pulmonary complications (PPC) after sternotomy are complex and not well understood. The frequency is reported to be from 7% to 79%. Furthermore between 11% and 56% of sternotomy patients suffer from persistent postoperative pain, a fact that is largely underestimated.
The health care system has additional costs of about $45,000 per patient with DSWI, or almost 3 times the cost of a normal procedure without complications ($18,000) [22]. Postoperative pulmonary complications and persistent pain add costs per patient of $28,000 and $6,000 respectively, however, since the rate of incidence is much higher, these complications represent a significantly higher economic burden on the health care system.
The major risk factors for sternal wound infection are obesity, breast size, diabetes, osteoporosis, chronic cough, tobacco use, chronic obstructive pulmonary disease (COPD), immuno-suppression, and CABG with use of the Internal Mammary Arteries (IMA). Women who need large bra cups have a 38.5% higher risk for deep sternal wound infection compared with women who need small bra cups. Women who need medium bra cups have a 12.3% higher risk for sternal wound infection.
Research reported in literature demonstrates the serious need for effective prevention of postoperative complications after sternotomy procedures to decrease health care costs and to improve patient's postoperative recovery experience. Since improved surgical techniques have not decreased the incidence of complications over the last decades, there is an increased need for postoperative devices that can complement the internal sternal closure through a lateral sternum reinforcement from the outside, assist patients to better manage their breathing and pain, and provide increased support when they cough, sneeze, strain or perform exercises in the rehabilitation period.
Following thoracic surgeries and in particular surgeries requiring access through the sternum bone, women in general, fuller-sized women in particular, and obese patients more in particular, encounter a significantly higher risk for postoperative complications such as sternal and pulmonary infections, as well as additional pain and wound healing complications caused by strain on the sternum bone from the weight of the breast tissue, and from the additional internal pressure caused by coughing, sneezing and straining e.g. during bowel movements and/or excessive and wrong use of upper extremities too early after surgery. The mass of breast tissue causes the gravity force to pull the tissue downwards when a person is in the standing or sitting position, and to the lateral sides when a person is in the horizontal position or leaning backwards. Such pulling force causes significant stress on a fresh sternum wound and on the two halves of the sternum bone that after surgery are only held together on the inside by surgical stainless steel wires, bands, plates or similar devices. The weight pull from the breast tissue will draw the two wound edges away from each other and may cause the skin sutures to cut through the skin and wound edges, breaking the wound open. Such open or partially open wound will increase the risk of wound infections, wound deformations, deeper wound rupture and cause additional pain. In an even worse scenario, the pulling force from heavy breast tissue will cause the sternum stainless steel wires, bands or plates to cut into or through the sternum bone. This will cause pain, sternum dehiscence, and significantly increase the risk for deep sternal wound infections, all which are very severe postoperative complications with high mortality rates and very high costs to cure.
Therefore the sternum must be supported laterally from the external side to complement and support the internal surgical closure, and the breast tissue, in particular fuller-sized breast tissue, must be supported and positioned to prevent gravity pulling forces in any direction on a wound in the chest and in particular a sternal wound which is placed centrally between the breasts. Furthermore a continuous external lateral support on the sternum bone is particularly important when the patient coughs, sneezes or when straining such as during bowel movements. These actions significantly increase the internal thoracic pressure up to as high as 300 mmHg. Such sudden increased thoracic pressure will cause additional stress on the sternum bone closure from the inside and increase the risk for rupture of the sternum closure, particularly if the sternum is unsupported from the external side. Therefore it is important not only to have a constant external chest support, but in addition to have means available to increase the external lateral support on the sternum to counteract such increased internal thoracic pressure and prevent postoperative complications.
Just as the pulling force on the wound caused by heavy breast tissue must be controlled and counteracted, the wound, and in particular a sternum wound must be protected from being squeezed from the sides by breast tissue. Such squeezing pressure on a wound will encapsulate the wound and generate heat and moisture, which can cause bacterial growth and result in severe wound infections. Therefore the breast tissue must gently be kept away from the wound, and particularly from a sternum wound, without introducing a pulling force on the wound, to prevent heat and moisture production with potential accompanying wound complications.
Additionally, squeezing a wound, and in particular a sternum wound, disturbs the natural healing process, and may result in deformation of the wound, which leaves an esthetically, unattractive scar in a highly visible place on a patient's chest. This may be a psychological problem for the patient postoperatively, and in particular, it may be a psychological problem for women postoperatively.
Inspection and care of a fresh surgical wound requires access by opening of the dressings, bands, brassieres and other devices which may cover the wound after surgery. Wound inspection and care represent particularly a problem in obese patients and fuller sized women, since the support of breast tissue is interrupted during such wound exposure. The gravity force will pull, cause pain and stress on the wound during care, whereby the risk of postoperative complications may increase. Therefore support of the breasts must be maintained at all times including when wound inspection and care is taking place to prevent such complications and the related increased costs of cure.
In addition, wound care of sternotomy patients with exposure of breasts may represent an issue for women of different ethnical origins. Therefore it is desirable particularly for this group of patients that the breast tissue is covered at all times including during wound care.
Accordingly there is a need for a postoperative sternum and breast device that provides a constant lateral support on the sternum from the external side to complement the internal closure and which has means for increasing such external lateral sternum support to counteract the significantly increased internal thoracic pressure during various normal physical situations such coughing, sneezing, straining, breathing exercises etc. Furthermore there is a need for a postoperative sternum and breast device that can counteract the gravity forces caused by excessive obesity and breast tissue to prevent pulling on a wound, and particularly a sternal wound, as well as gently keep such sternal wound free of breast tissue. Furthermore there is a need for a postoperative sternum and breast device that in addition can provide access for wound care without the need to fully open such device and maintain women dignity during said wound care. Furthermore there is a significant need for a postoperative sternum and breast device that is comfortable to use day and night to assure that patients will comply with usage of such device in a period as long as 6-8 weeks until the wound and particularly a sternal wound is properly healed.
A surgical chest dressing is described in U.S. Pat. No. 6,135,975 to Johnstone which incorporates by reference U.S. Pat. No. 3,968,803 to Hyman; U.S. Pat. No. 5,152,741 to Farnio; and U.S. Pat. No. 5,538,502 to Johnstone. The described chest dressing is a brassiere directed towards improved support and comfort of the chest dressings and is “designed to improve support for a patient by holding the breasts of the patient relatively immobile while pressing them slightly toward the line of the incision”. However, the surgical chest dressing described is squeezing a patient's side and breast tissue towards the center, whereby a wound in the thoracic area, and in particular a sternal wound, will be exposed to excessive pressure and heat-moist generation from the two breasts being pressed towards each other causing discomfort and pain for a woman with a fresh surgical wound, and in particular for obese and fuller-sized women. Such excessive pressure, heat-moist generation will result in increased potential for wound infections and other complications related to wound healing, as well as scar deformation. These are all complications that will lead to increased health care costs. Furthermore, there is no means for a continuous external support to the sternum in this device.
U.S. Pat. No. 4,804,351 to Rami et al. describes a surgical brassiere directed towards reducing stress along the mid-sternal incision line. The device has a pair of bust support cups and a ventilated panel over the gap between the cups. The ventilated panel can be opened for wound care and discloses how “a pair of inner straps, detachably secured across the gap between the bust support cups, assure that support continues to be provided while the ventilated panel is thus unsecured”. However, while the brassiere may remain closed during wound care, there is no means to position the breast tissue to prevent gravitation to the sides, or to prevent the breast cups to squeeze the breast tissue towards the center. This will cause extra pulling stress and/or squeezing on a sternal wound and cause discomfort and pain for a patient, and in particular for obese patients and fuller-sized women. Such wound stress can result in increased infection and complication rates, which will lead to increased health care costs when treating such complications. Furthermore, there is no means for a continuous external support to the sternum in this invention.
U.S. Pat. No. 5,797,786 to Smith et al. describes a post-operative brassiere that has been “developed to provide a post-operative brassiere which completely eliminates the conventional torso straps that interconnect the bust support cups so as to form an exposed gap over the area of the patient's mid-sternal incision line to help promote healing and recovery”. However, the brassiere has no means to stabilize the breast support cups and prevent gravitation to the sides or to prevent squeezing of the breast tissue towards the center. This will cause pulling stress and/or squeezing on a sternal wound and cause pain and discomfort for a fuller-sized woman, and in particular for obese patients. Such wound stress results in increased infection and complication rates, which will lead to increased health care costs when treating such complications. Furthermore, there is no means for a continuous external support to the sternum in this invention.
Sports bras and brassieres for athletic use generally aim at supporting and immobilizing the breasts to allow women to perform sports activities in a comfortable and painless way. Some of these brassieres are devoted to women with a large bust, such as U.S. Pat. No. 5,221,227 to Michels and U.S. Pat. No. 6,165,045 to Miller et al. Sports brassieres are sometimes employed to patients post-operatively for breast support. However, since they are designed for sports activities, they are generally not suitable for postoperative use and do not meet the specific needs both patients and health care personnel require after surgery. Furthermore, sports bras and brassieres have no means for a continuous external support to the sternum.
A brassiere for strenuous physical activity is described in U.S. Pat. No. 4,254,777 to Johnston and shows the use of “extra facings” around the bra cups to prevent undue movement of the breasts. These “facings” have no means to be adjusted and are too thin to give support or direct the position of a breast. Furthermore, there is no means for a continuous external support to the sternum in this invention.
A number of compression brassieres are available for use post-operatively for surgeries such as breast augmentation, reconstructive breast surgeries and other surgeries in the breast(s). Such compression brassieres have drawbacks and are not suitable for postoperative use after interventions inside the thorax, e.g. cardiothoracic surgery, since these devices are designed to compress the breast tissue with the aim to eliminate or reduce swelling caused by accumulation of lymph fluids after a surgical intervention in the breast(s), and/or to press downward newly inserted breast implants. A drawback for cardiothoracic patients using compression brassieres is that the breast tissue is compressed inwards, thereby squeezing and spreading the breast tissue over the thoracic wall in all directions. Such compression is very uncomfortable and painful and may cause healing complications for the wound, and in particular for a sternal wound, which will be exposed to undesirable high pressure and heat-moisture generation. This will increase the rate of wound infections and wound deformations. In particular, such undesirable high pressure on a sternal wound will increase the rate of wound complications in obese patients and for fuller-sized women. All postoperative complications lead to increased health care costs, when they need to be treated. Furthermore, these devices have no means for a continuous external support to the sternum.
Examples of prior art for a compression and post-partum breast engorgement bra are described in U.S. Pat. No. 5,839,942 to Miller and other compression devices are disclosed in U.S. Pat. No. 5,098,331 to Corrado; U.S. Pat. No. 5,037,348 to Farino; and U.S. Pat. No. 7,144,294 B2 to Bell et al.
A compression bra is described specifically for symmastia in U.S. Pat. No. 7,666,058 B2 to Smith. This design is directed towards a “compression stabilizing, supporting and positioning bra for addressing and/or correcting symmastia complications in reconstructive breast surgeries . . . ” and has a “flared, trapezoidal shaped, sternum compression panel secured at its base to the upper edge of the torso band below the inframammary skinfold and at the top, by a pair of adjustable shoulder straps for elastically compressing sternum tissues while restraining shaping and separating the inside conically rising, side portions of a woman's breasts”. While the device described obviously cannot be utilized for patients having had a sternotomy, it aims at “supporting and positioning” the breasts. However, there is no means to prevent gravitation of the breast tissue to the central or the lateral sides. Furthermore, the adjustable shoulder straps that are attached to a panel for elastically compressing the sternum tissue between a woman's breasts only pull a panel upwards and cannot support or direct a breast in any direction. There is no means for a continuous external support to the sternum in this invention.
In view of the foregoing, it is a general object of the present invention to provide a sternum and breast device that overcomes the problems of prior art devices and that can improve the postoperative care and experience for patients, decrease and prevent postoperative complications, and thereby decrease costs of health care in accordance with the features set forth in the claims that follow. The invention also includes a corresponding method.